Saturday, 08 November 2025

Partner 5: Institut National de la Santé et de la Recherche Medicale (INSERM-CTU)

INSERM SC10, HIV Clinical Trial Unit was created in 1990 and works together with the ANRS (Agence Nationale de Recherche sur le SIDA et les hépatites virales) to provide methodological design, implementation, statistical analysis and scientific valorisation of therapeutic trials in HIV infection and viral hepatitis. Since its creation, the SC10 has undertaken about 40 trials including around 6000 patients in France. These phase I to phase IV trials, promoted by public sponsors, evaluate new drugs for specific needs and new therapeutic strategies. All these studies are developed at national level within the network organised by SC10 when the first INSERM trials were launched. To date, this network consists of around one hundred hospital sites located all over the country. It includes clinical services, pharmacies, virology and immunology laboratories. INSERM SC10 works in interaction with 3 international networks: The NEAT group (including about sixteen European countries: a prolongation of the INSERM/MRC network initially established between France and UK for the Concorde, Alpha, Delta and Initio trials); the ACTG network (the US AIDS clinical trials group: ACTG and IMPAACT); the PENTA group (Paediatric European Network for Treatment of AIDS). PENTA trials are co-ordinated together with MRC/CTU. PENTA arise questions about treatment for HIV that can not be answered by adult trials. In this sense PENTA carried out clinical trials enrolling more than 1200 children in 80 sites and laboratories in 16 countries (13 Europe, 2 in Latin America and 1 in Thailand). INSERM SC10 is member of TEDDY (Task European Force for Drug Development in Young) since 2005 whose overall aim is to promote the availability of safe and effective medicines for children in Europe.The Good Clinical practices (GCP) are among the early concerns of the trials management centre. Efforts are made towards both directions: the quality for producing the data in trials enhanced by telematics means - which allow data control in real time - and the confidentiality and ethics. The quality insurance activity is rapidly expanding with the continuing education to GCP for all the different team members and assessment of standard operating procedures application through audits conducted by independent party.

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